does cbd oil keep you awake

We have also reviewed your social media website at www.facebook.com/naturalnativecbd ; this website directs consumers to your website naturalnative.com to purchase your products . The claims on your websites and social media website establish that your “20 oz. Native CBD Water,” “CBD Baby Bears,” “CBD Big Bears,” “CBD Hemp Oil, Raspberry, 300mg,” “Liposomal CBD Extract Spray,” “Native 225 mg – Raspberry 15 ml Broad Spectrum CBD Spray,” and “CBD Balm – 250mg” products are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. Furthermore, your products are misbranded drugs under section 502(f)(1) of the FD&C Act, 21 U.S.C.

FDA has also determined that your “Native Pet CBD Oil (150mg, 300mg, & 600mg)” product is an unapproved new animal drug that is unsafe under section 512(a) of the FD&C Act, 21 U.S.C. 360b(a), and adulterated under section 501(a)(5) of the FD&C Act, 21 U.S.C. Native CBD Water” product is adulterated under section 402(a)(2)(C)(i) of the FD&C Act, 21 U.S.C. 342(a)(2)(C)(i), because it bears or contains an unsafe food additive. Furthermore, it is a prohibited act to introduce your “20 oz. CBD Water” product into interstate commerce under section 301(ll) of the FD&C Act, 21 U.S.C. As explained further below, introducing or delivering these products for introduction into interstate commerce violates the FD&C Act. You can find the FD&C Act and FDA regulations through links on FDA’s home page at www.fda.gov .

You can find specific information about how FDA regulates CBD at https://www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-including-cannabidiol-cbd . The Agency is particularly concerned that you market your unapproved new drug products for infants. Specifically, a post to your Facebook page links to an article entitled “CBD for Brain-Damaged Babies?” in which the following statement is made, “[t]he launch of a clinical trial examining the use of CBD in newborns suffering from hypoxic ischemic encephalopathy (brain damage caused by lack of oxygen) means new hope for the million plus babies born each year with this condition.” Your product has not been evaluated by the Agency for safety, effectiveness, and quality. The use of untested drugs can have unpredictable and unintended consequences, especially in vulnerable populations. For example, infants may be at greater risk for adverse reactions associated with certain drug products due to differences in the ability of infants to absorb, metabolize, distribute, or excrete such drug products or their metabolites. Your product labels for “CBD Baby Bears,” “CBD Hemp Oil, Raspberry, 300mg” and “Native 225 mg Raspberry – 15 ml Broad Spectrum CBD Spray” products contain Supplement Facts panels, which indicates that you intend to market these CBD products as dietary supplements. However, your products cannot be dietary supplements because they do not meet the definition of a dietary supplement under section 201(ff) of the FD&C Act, 21 U.S.C. FDA has concluded that, based on available evidence, CBD products are excluded from the dietary supplement definition under sections 201(ff)(3)(B)(i) and (ii) of the FD&C Act, 21 U.S.C. [1] Under those provisions, if an article (such as CBD) is an active ingredient in a drug product that has been approved under section 505 of the FD&C Act, 21 U.S.C. 355, or has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are outside the definition of a dietary supplement. There is an exception if the substance was “marketed as” a dietary supplement or as a conventional food before the new drug investigations were authorized; however, based on available evidence, FDA has concluded that this is not the case for CBD. FDA is not aware of any evidence that would call into question its current conclusion that CBD products are excluded from the dietary supplement definition under sections 201(ff)(3)(B)(i) and (ii) of the FD&C Act, 21 U.S.C. 321(ff)(3)(B)(i) and (ii), but you may present FDA with any evidence bearing on this issue. Native CBD Water,” “CBD Baby Bears,” “CBD Big Bears,” “CBD Hemp Oil, Raspberry, 300mg,” “Liposomal CBD Extract Spray,” “Native 225 mg – Raspberry 15 ml Broad Spectrum CBD Spray,” and “CBD Balm – 250 mg” products are drugs under section 201(g)(1) of the FD&C Act , 21 U.S.C. 321(g)(1), because they are intended for use in the cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or any function of the body. Examples of claims observed on your website, wa.naturalnative.com , and your social media account, www.facebook.com/naturalnativecbd , that establish the intended uses of your products as drugs include, but may not be limited to, the following: On the website www.naturalnative.com ; webpage titled “WHAT IS CBD?”: “Although CBD doesn’t make people feel high like THC does, it’s causing quite a buzz among scientists, health professionals, and medical marijuana patients who are using CBD-rich products to treat a wide range of conditions – chronic pain, cancer, Crohn’s, diabetes, rheumatoid arthritis, PTSD, cardiovascular disease, anxiety, antibiotic-resistant infections, multiple sclerosis, schizophrenia, and more.” “Extensive preclinical research and some clinical studies have shown that CBD has strong anti-oxidant, anti-inflammatory, anticonvulsant, anti-depressant, anti-psychotic, anti-tumoral ( sic ), and neuroprotective qualities. Cannabidiol can change gene expression and removal beta amyloid plaque, the hallmark of Alzheimer’s, from brain cells.” On the website https:// wa.naturalnative.com : product page for “Raspberry Flavored CBD Oil Sample 150 mg”: “Pure Hemp Extract is know ( sic ) to help with Chronic Pain and Inflammation.” “[E]ffects can help curb anxiety from stress…” On the website https:// wa.naturalnative.com : product page for “CBD Balm – 250 mg”: “Natural Native hemp balm is a CBD isolate infused with all organic ingredients and is absorbed through the skin to give localized relief of pain, soreness, and inflammation …” On your Facebook social media account www.facebook.com/naturalnativecbd : June 20, 2019 posting linking to an article entitled “CBD for Brain-Damaged Babies?” in which the following statement is made, “[t]he launch of a clinical trial examining the use of CBD in newborns suffering from hypoxic ischemic encephalopathy (brain damage caused by lack of oxygen) means new hope for the million plus babies born each year with this condition.” November 19, 2018 posting – “CBD … has been shown to have anti-aging properties, and the anti-inflammatory properties have been shown to reduce acne!!” November 6, 2018 posting – “There is ongoing research about utilizing cannabis to treat chronic pain, improve memory function, sustain metabolic health, and regulate blood sugar.” May 19, 2018 posting entitled “Cancer Institute Finally Admits Marijuana Kills Cancer” in which you commented, “And so does the LEGAL cousin Hemp CBD!” May 6, 2018 posting with a picture showing, “CBD benefits for Pain, Mental Illness, Anxiety & More.” March 11, 2018 posting with an infographic which states CBD is: “antibacterial” “Inhibits cancer cell growth” “Reduces blood sugar levels” “Reduces inflammation” “Reduces risk of artery blockage” “Reduces small intestine contractions” “Reduces vomiting & nausea” “Relieves pain” “Relieves anxiety” “Suppresses muscle spasms” “Treats fungal infection” “Treats psoriasis” “Vasorelaxant” Second March 11, 2018 posting with an infographic which states: “Suppresses muscle spasms” “Immunosuppressive (Lupus, RA)” “Anti-Diabetic – Reduces blood sugar” “Anti-Psychotic – Tranquilizing” “Reduces vomiting and nausea” “Anti-depressant” “Antibacterial” “Relieves anxiety” “Relieves Pain” “Inhibits cell growth in tumors and cancer cells” “Promotes Bone Growth” “Aids psoriasis” “Reduces risk of artery blockage” January 12, 2018 posting – “If you are not seeing the results you want, you may want to increase your intake for chronic issues; like pain caused by arthritis and other causes of inflammation …” December 14, 2017 posting – “Natural Native Hemp CBD Balm is the most popularly chosen for localized pain relief, muscle soreness, tension, and inflammation, but anecdotal evidence is beginning to show a widening spectrum of potential benefits, from psoriasis, dermatitis, and itching to headaches and cramping. Arthritic pain is caused by inflammation, CBD works well to get rid of inflammation and the pain that comes with it.” Your “20 oz. Native CBD Water,” “CBD Baby Bears,” “CBD Big Bears,” “CBD Hemp Oil, Raspberry, 300mg,” “Liposomal CBD Extract Spray,” “Native 225 mg – Raspberry 15 ml Broad Spectrum CBD Spray,” and “CBD Balm – 250mg” products are not generally recognized as safe and effective for the above referenced uses and, therefore, these products are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the FDA, as described in sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective. There are no FDA-approved applications in effect for any of the above-mentioned products. Native CBD Water,” “CBD Baby Bears,” “CBD Big Bears,” “CBD Hemp Oil, Raspberry, 300mg,” “Liposomal CBD Extract Spray,” “Native 225 mg – Raspberry 15 ml Broad Spectrum CBD Spray,” and “CBD Balm – 250mg” products are also misbranded within the meaning of section 502(f)(1) of the FD&C Act, 21 U.S.C.

352(f)(1), in that their labeling fails to bear adequate directions for use. “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended. (See 21 CFR 201.5.) The aforementioned products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes. FDA-approved prescription drugs that bear their FDA-approved labeling are exempt from the requirements that they bear adequate directions for use by a layperson. However, your products are not exempt from the requirement that their labeling bear adequate directions for use, 21 CFR 201.100(c)(2) and 201.115, because no FDA-approved applications are in effect for them.

The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act, 21 U.S.C. Furthermore, it is a prohibited act under section 301(ll) of the FD&C Act, 21 U.S.C. 331(ll), to introduce or deliver for introduction into interstate commerce any food to which has been added a drug approved under section 505 of the FD&C Act or for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public. Based on available evidence, FDA has concluded that the prohibition in section 301(ll) applies to CBD.

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